Medical Devices Design & Development Services

We do both. Our medical device design services and engineering services cover the full stack, from PCB design and enclosure engineering to firmware, embedded software, and cloud platforms. This range of services means one team handles hardware and software together, so nothing gets lost in handoffs between vendors.

That’s what we do! We offer medical device software engineering for SaMD products, from risk analysis and UI design to cloud connectivity and compliance.

We operate under an ISO 13485-certified quality management system. Our engineering processes align with IEC 62304 for software lifecycle management, IEC 60601 for electrical safety, and 21 CFR 820 for design controls. We also follow IEC 62443 for cybersecurity where connected devices are involved.

Yes. We provide software design for medical devices in line with FDA and MDR regulations, as well as ISO 13485 and IEC 62304 standards, to support smooth approvals and safe releases. That applies to software development for medical devices as well.

Yes. We prepare technical documentation per EU MDR 2017/745, support Notified Body audits, and help with CE marking for European market access. We also handle multi-market strategies through MDSAP, which covers the US, Canada, Brazil, Australia, and Japan.

Class II covers moderate-risk devices like infusion pumps and powered wheelchairs. Class III is for high-risk products such as implantable pacemakers. For Class II, we typically follow the 510(k) pathway with a 12 to 24 month timeline. Class III requires PMA approval with clinical evidence, and usually takes 3 to 7 years. Our design controls and testing scale with the regulatory requirements of each class.

For most Class II devices going through the 510(k) pathway, you can expect 12 to 24 months from concept to clearance. Class III devices that need PMA approval typically take 3 to 7 years because of clinical trial requirements and longer FDA review cycles. We work to shorten those timelines by running hardware and software development in parallel and starting documentation early.

The biggest factors are device class, regulatory pathway, and how much groundwork is already in place. Class II devices with a clear 510(k) predicate generally move faster and cost less, while Class III products requiring PMA take significantly longer and carry higher costs because of clinical trials and extended review cycles. We shorten development timelines by running hardware, firmware, and software in parallel and starting regulatory documentation from the first sprint. Since every project is different, the best way to get a realistic estimate is to talk to our team about your specific device and regulatory situation.

Challenges in medical device software development often originate from poor vendor documentation or integrating multiple devices. We handle this by working with vendors directly or suggesting better-documented alternatives. For multi-device setups, we merge and normalize data to ensure smooth processing. Every project is unique, so issues may vary.

We can. Yalantis is a medical device design firm that also delivers medical device interoperability services, supporting integration with EHRs, hospital platforms, and HL7/FHIR standards.

We develop medical device software solutions that standardize and synchronize data across various devices, so the data exchange is smooth and compliant.

Yes, we do it as part of our medical device software development services. We conduct strict verification and validation (V&V) testing to ensure software safety, reliability, and compliance.

We’ve delivered medical device engineering services for all classes of FDA-approved devices and built custom medical device solutions from scratch. Our team develops medical device software for diagnostics, remote monitoring, and chronic disease management, and we offer consulting and ongoing outsourcing when needed. This makes us a long-term partner for healthcare companies that require seamless data integration and dependable outcomes.